Product Name: Ipratropium Bromide
Chemical Formula: C20H30BrNO3
Trade Names: Atrovent, Aerovent, Ipravent
CAS Number: 22254-24-6
Synonyms: (8r)-3-alpha-Hydroxy-8-isopropyl-1-alphaH,5-alpha-tropanium bromide
Use: Pharmaceutical applications primarily for bronchodilation in respiratory therapy
Manufacturer’s Contact: Information can be found on the product labeling supplied by the pharmaceutical provider or distributor
Emergency Phone Number: Provided by manufacturer or local poison control center
GHS Classification: Acute toxicity (Oral, Category 4), Eye irritation (Category 2A), Specific target organ toxicity - single exposure (Category 3, Respiratory system)
Signal Word: Warning
Hazard Statements: Harmful if swallowed, Causes serious eye irritation, May cause respiratory irritation
Pictograms: Exclamation mark
Precautionary Statements: Avoid breathing dust or aerosols, wash thoroughly after handling, wear protective eye and respiratory protection
Potential Health Effects: May irritate eyes, skin, and respiratory tract; ingestion may cause gastrointestinal disturbance, weakness, dry mouth, tachycardia, and urinary retention, large doses may induce anticholinergic effects
Environmental Hazards: Possible risk to aquatic life at high concentrations
Chemical Name: Ipratropium Bromide
Concentration: Pure compound (active pharmaceutical ingredient), formulation may include sodium chloride, water for inhalation, benzalkonium chloride as preservative
Impurities and Stabilizing Additives: Not normally present in pharmaceutical-grade material
Other Components: Inhalers and nebulizer solutions include aqueous solution, with other excipients depending on manufacturer
Inhalation: Move person to fresh air, monitor for respiratory distress, seek medical attention if symptoms persist
Skin Contact: Wash off with plenty of soap and water, remove contaminated clothing
Eye Contact: Rinse cautiously with water for at least 15 minutes, keep eyelids open, seek ophthalmic advice for irritation
Ingestion: Rinse mouth thoroughly, do not induce vomiting, obtain medical advice promptly if large amounts swallowed
Note to Physicians: Treat symptomatically, watch for anticholinergic toxicity
Suitable Extinguishing Media: Use water mist, dry chemical, foam, or carbon dioxide
Unsuitable Extinguishing Media: Strong water jet may spread material
Specific Hazards Arising from Substance: Decomposition may produce irritating or toxic fumes including nitrogen oxides, hydrogen bromide
Protective Equipment for Firefighters: Full protective clothing, self-contained breathing apparatus
Special Precautions: Cool exposed containers with water spray, avoid inhalation of combustion products
Personal Precautions: Remove unnecessary personnel, ventilate area, avoid dust formation, use personal protective equipment
Environmental Precautions: Prevent product from entering drains, surface water or soil
Methods for Containment and Cleaning Up: Sweep up or vacuum spilled material, place in appropriate waste container for disposal, wipe surfaces with damp cloth, wash spill area thoroughly
Handling: Handle in well-ventilated area, avoid contact with eyes, skin, and clothing, avoid inhalation of dusts or aerosols, use within expiration date
Technical Measures: Local exhaust ventilation, dust control, minimize airborne exposure
Storage Conditions: Store in tightly closed, original container in cool, dry place away from incompatible substances; protect from light, moisture, and excess heat
Incompatibilities: Strong oxidizing agents, strong acids and bases
Special Packaging Requirements: Preserve in tightly sealed containers with labeling according to regulations
Occupational Exposure Limits: No occupational exposure limit established for Ipratropium Bromide, minimize exposure as with any pharmaceutical agent
Engineering Controls: Ventilated enclosures, fume hood where feasible
Respiratory Protection: NIOSH/OSHA approved respirator if airborne dust or aerosol risk present
Eye Protection: Chemical safety goggles, face shield if risk of splashing
Skin Protection: Protective gloves, lab coat, long sleeves
Hygiene Measures: Wash hands after handling, avoid eating, drinking or smoking in work areas, remove contaminated clothing promptly
Appearance: White to off-white crystalline powder
Odor: Odorless
Molecular Weight: 412.36 g/mol
Melting Point: 230 to 240°C
Solubility: Freely soluble in water and methanol, slightly soluble in ethanol, practically insoluble in chloroform and ether
pH (1% solution): 3.0-4.5
Partition Coefficient: logP: -1.2
Boiling Point: Data not available (material decomposes)
Vapor Pressure: Not applicable (non-volatile)
Chemical Stability: Stable under recommended conditions, sensitive to strong heat and light over time
Reactivity: Normally unreactive under anticipated storage and use conditions
Hazardous Reactions: Not likely under normal conditions
Conditions to Avoid: Excessive heat, strong oxidizers, contact with acids or bases
Hazardous Decomposition Products: May form carbon oxides, nitrogen oxides, hydrogen bromide under fire or thermal decomposition
Polymerization: Will not occur
Routes of Exposure: Inhalation, skin and eye contact, ingestion
Acute Toxicity: LD50 (oral, rat): 600 mg/kg; LD50 (intravenous, rat): 12 mg/kg
Symptoms: Dry mouth, blurred vision, tachycardia, urinary retention, constipation, central nervous system effects at high exposure, local irritation
Chronic Effects: No evidence of carcinogenicity or mutagenicity in long-term animal studies; safe therapeutic use documented, chronic misuse may aggravate pre-existing disorders
Irritation/Corrosion: Mild irritant to skin and eyes
Reproductive/Developmental Toxicity: Animal studies indicate low reproductive risk at therapeutic doses
Aquatic Toxicity: Acute toxicity for fish and daphnia expected to be low at environmentally relevant concentrations
Persistence and Degradability: Product anticipated to be biodegradable over time
Bioaccumulation Potential: Low logP value suggests low potential for bioaccumulation
Mobility in Soil: Soluble and likely to leach in aqueous environments
Other Adverse Effects: Phytotoxicity not expected in diluted effluent, but prudent to avoid uncontrolled release
Waste Treatment Methods: Incinerate in approved facility or dispose of in accordance with local, regional, and national regulations
Container Disposal: Rinse empty containers with water before discarding in line with waste medication protocols
Precautions: Do not dispose of in sewer system or regular waste streams
Hazardous Waste: Product classified as hazardous pharmaceutical waste; coordinate with licensed hazardous waste contractor
UN Number: Not regulated for transport according to international transport regulations
Proper Shipping Name: Not classified as dangerous goods
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Environmental Hazards: Not considered a marine or aquatic pollutant
Special Precautions: Avoid excessive heat and crush damage during transit, handle as a pharmaceutical material
Safety, Health and Environmental Regulations: Controlled according to pharmaceutical legislation in many jurisdictions, subject to FDA (US), EMA (EU), ICH standards
OSHA Status: Not listed as hazardous chemical under US OSHA Hazard Communication Standard
TSCA: Exempt as a pharmaceutical ingredient
WHMIS (Canada): Not classified under current Canadian regulations
REACH (EU): Registered for medicinal and research use
Other Information: Adhere to specific workplace, hospital, or clinic safety management policies; report occupational exposure as required
